Kornimate/medical-research-clean huggingface dataset:
open-label study of the efficacy and safety of vesicare® in patients with overactive bladder symptoms

Conditions: Urinary Bladder, Overactive

Summary: to evaluate the safety and efficacy of solifenacin succinate in subjects with overactive bladder symptoms (urgency, with or without urge incontinence, usually with frequency and nocturia).

study included a 24 week extension that did not occur due to fda approval of the product.

Eligibility criteria:
inclusion criteria: * symptoms of oab (urgency, with or without urge incontinence, usually with frequency and nocturia) for ≥3 or more months. * patients may be included if they are on another oab medication; however, patients must washout from other oab medications for at least 7 days prior to receiving solifenacin succinate. previous non-drug treatment of oab is allowed if it has been established at least 4 weeks prior to study entry and is continued throughout the study. exclusion criteria: * -significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor * evidence of urinary tract infection; chronic inflammation such as interstitial cystitis and bladder stones * clinically significant outflow obstruction (benign prostatic hyperplasia)

Keywords: urinary bladder, overactive urgency vesicare® solifenacin succinate
emerald (emergency medicine cardiovascular risk assessment for lipid disorders)

Conditions: Lipid Disorder

Summary: the emerald intervention involves 1) ordering an emergency department (ed) lipid panel, 2) calculating 10-year atherosclerotic cardiovascular disease (ascvd) risk using the pooled cohort equations, 3) prescribing a moderate- or high-intensity statin if applicable, and 4) referring patients to outpatient care (primary care, preventive cardiology, or general cardiology, depending on risk level).

emerald (emergency medicine cardiovascular risk assessment for lipid disorders) is a pilot study seeking to determine the feasibility of initiating medical therapy for hyperlipidemia (hld) in the emergency department (ed) and will collect data essential to inform a future randomized controlled trial comparing ed hld treatment to usual care. hld is a key cardiovascular disease (cvd) risk factor that is causally associated with atherosclerotic cardiovascular disease (ascvd), the leading cause of us mortality and morbidity.

Eligibility criteria:
inclusion criteria: * emergency department (ed) patients with chest pain * 40-75 years old * a low-density lipoprotein cholesterol (ldl-c) ≥70 mg/dl on an ed lipid panel or have known diabetes or atherosclerotic cardiovascular disease (ascvd) exclusion criteria: * subject unwilling to take study medication * pregnancy or breastfeeding * inability to take study medication or, in the opinion of the investigators/subject's doctors unsuitable for study participation * st-segment elevation myocardial infarction (stemi) activation * st-segment depression \>1 mm * on a lipid lowering agent (statin, pcsk9 inhibitor, bempedoic acid, ezetimibe, inclisiran) * unstable vitals (blood pressure (bp) \ 120 or \<50, o2 sat \<90%) * statin intolerance * high-sensitivity troponin i ≥100 ng/l * end-stage renal disease (esrd) and/or glomerular filtration rate (gfr) \<30 ml/min/1.73 m2 * liver cirrhosis * hospitalization * life expectancy \<1 year * transfer from another hospital * prisoner * non-english speaking

Keywords: hyperlipidemia cardiovascular disease atherosclerotic cardiovascular disease
matched unrelated vs. haploidentical donor for allogeneic stem cell transplantation in patients with acute leukemia

Conditions: Acute Myeloid Leukemia in Remission; Acute Lymphoblastic Leukemia in Remission; Myelodysplastic Syndromes

Summary: primary objective of this open label, two-arm, multicenter, multinational, randomized trial is to compare anti-leukemic activity of allogeneic stem cell transplantation for patients with acute leukemia in complete remission between a 10/10 hla matched unrelated donor and a haploidentical donor. the hypothesis: haploidentical stem cell transplantation with post cyclophosphamide induces a stronger anti-leukemic activity in comparison to 10/10 hla matched unrelated donor and reduces the risk of relapse at 2 years after stem cell transplantation by 10%.

secondary objectives are to assess and compare the safety and efficacy of study treatments therapy in both study arms on non-relapse mortality (nrm), relapse-free survival (rfs), overall survival (os), qol, toxicity, development of acute and chronic gvdh as well as engraftment and chimerism and impact of measurable residual disease.

Eligibility criteria:
inclusion criteria 1. acute myeloid leukemia (aml) intermediate or high risk according to eln or acute lymphoblastic leukemia (all) high risk according to esmo guidelines in 1. cr or aml/all in 2. cr, or high risk mds (according to ipss-r) in 1. cr or 2. cr. 2. patients age: 18 - 70 years at time of inclusion (female and male). 3. patients understand and voluntarily sign an informed consent form. 4. ecog ≤ 2. 5. 10/10 hla-matched unrelated donor and haploidentical (≥ 5/10 and ≤ 8/10 hla) relative matched donor available at least 4 weeks after completion of induction and/or consolidation therapy. 6. females/males who agree to comply with the applicable contraceptive requirements of the protocol. exclusion criteria 1. severe renal, hepatic, pulmonary or cardiac disease, such as: * total bilirubin, sgpt or sgot \> 3 times upper the normal level * left ventricular ejection fraction \< 30 % * creatinine clearance \< 30 ml/min * dlco \< 35 % and/or receiving supplementary continuous oxygen 2. positive serology for hiv. 3. pregnant or lactating women (positive serum pregnancy test). 4. age \< 18 and ≥ 71 years. 5. uncontrolled invasive fungal infection at time of screening (baseline). 6. serious psychiatric or psychological disorders. 7. participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment. 8. uncontrolled severe autoimmune disease or uncontrolled other malignancy. 9. availability of an hla-identical sibling as donor source.

Keywords: acute myeloid leukemia acute lymphoblastic leukemia myelodysplastic syndromes allogeneic stem cell transplantation matched unrelated allogeneic stem cell transplantation haploidentical allogeneic stem cell transplantation anti-leukemic activity cyclophosphamide as gvhd prophylaxis
role of tap and rs block in reduction of postoperative pain for gynecological surgical laparoscopic procedures

Conditions: TAP and RS Block

Summary: the present study aims to demonstrate the effectiveness of loco-regional wall anesthesia of the transversus abdominis plane block (tap block) and the rectus sheath block (rs block), compared to intravenous analgesia, in terms of pain reduction, postoperative analgesic drugs consumption, patient satisfaction and decrease of los (length of stay), in patients undergoing benign gynecological laparoscopic surgical procedures.


Eligibility criteria:
inclusion criteria: * patients undergoing benign laparoscopic gynecological surgery * age between 18 and 75 years * bmi \>18 e \<35 * ecog performance status 0-1 exclusion criteria: * age \ 75 years * bmi \ 35 * ecog performance status \>1 * allergy to local anesthetics * allergy to nsaids * chronic kidney failure \> ii class * systemic neoplastic disease actual or previous * actual pregnancy * active or recent pelvic inflammation * persistent coagulopathy * previous opioids consumption for chronic pain * neurological or cognitive disorders * conversion from laparoscopic to open surgery * onset of intraoperative complications
strength training with eccentric arm-cranking in para-athletes

Conditions: Spinal Cord Injuries

Summary: the new training device, the eccentric arm-crank, will be examined for its training effects in athletes with a spinal cord injury (sci) by this project. that the training device can be used in patients with paraplegia in the future, the so-called "testing of the applicability of this concept" will be carried out during this study. fourteen volunteer, healthy athletes with sci are first tested for their upper body performance, followed by a training phase over 20 trainings and at the end the performance data is collected again. the training intensity and duration is continuously increased during the training phase.

at the beginning, the study design includes a familiarisation appointment with performance tests and training on the eccentric arm-crank device (kreha). at least one week later, the first test sequence including a maximum strength test (bench press) and a test to determine the anaerobic performance (wingate test) is conducted. the second test sequence takes place one to three days later. this includes a handgrip strength test, an aerobic endurance test (ramp test on the arm crank ergometer with ergospirometry) and a further familiarisation training on the kreha. the training phase starts within two weeks after the pre-tests have been completed. there are two to a maximum of three trainings per week. these take 30 to 45 minutes and take place on the kreha device under the supervision of the study staff. the training phase lasts a maximum of twelve weeks (20 training sessions). the first test sequence is repeated five to eight days after the last workout. the second test sequence takes place at the same time interval as in the pre-tests.

Eligibility criteria:
inclusion criteria: * male or female with traumatic or disease-related sci * age between 18 and 50 years * experience in strength training * squad status or at least 4h per week training * biceps/triceps function * healthy(study physician) * adequately informed and confirmed per signature exclusion criteria: * findings during anamnesis of study physician * pregnancy

Keywords: eccentric strength training
laboratory testing for tie-2 expressing monocytes (tems) in blood

Conditions: Advanced Cancer; Healthy

Summary: tie-2 expressing monocytes (tems) are a specific type of blood cell that are present in healthy individuals and in people with cancer. these cells may play a role in the growth of blood vessels (veins/arteries), and may be particularly important in the growth of blood vessels that supply tumours. understanding how these cells work may therefore help researchers to develop cancer treatments that starve tumors of their blood supply. this research study involves an analysis of the behaviour of blood cells in response to different drugs in a test tube. the goal is to develop tests that can then be used to monitor patients treated with drugs that target blood vessel growth.


Eligibility criteria:
inclusion criteria: * healthy volunteers * ability to understand and the willingness to sign a written informed consent document. * patients with advancer cancer * participants must have histologically confirmed metastatic or unresectable solid tumors. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * healthy volunteers * history of cancer within the past 5 years * major medical condition undergoing active therapy * patients with advancer cancer * active hematologic malignancy (leukemia, lymphoma, myeloproliferative disorder). * active treatment on a phase i clinical trial

Keywords: advanced cancer healthy blood sample tem tie-2 expressing monocytes ang1 ang2
a depot formulation of sunitinib malate (gb-102) in subjects with diabetic macular edema and retinal vein occlusion

Conditions: Diabetic Macular Edema; Retina Vein Occlusion

Summary: phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety, tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels of gb-102 on subjects with diabetic macular edema and retinal vein occlusion

phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety, tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels (1 mg and 2 mg) of gb-102 on subjects with diabetic macular edema and retinal vein occlusion who have received prior treatment with anti-vascular endothelial growth factor (vegf)

Eligibility criteria:
inclusion criteria: * males or females ≥ 21 years of age * known diagnosis of macular edema secondary to diabetic macular edema or retinal vein occlusion treated with at least 3 prior ivt injections of an anti-vegf agent (aflibercept, bevacizumab, or ranibizumab) * demonstrated response to prior anti-vegf treatment since diagnosis * bcva of 31 letters or better exclusion criteria: * history, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke * uncontrolled hypertension, diabetes mellitus or iop * chronic renal disease

Keywords: macular edema
physical exercise augmented cbt for gad

Conditions: Generalized Anxiety Disorder

Summary: generalised anxiety disorder (gad) is a severe and debilitating anxiety disorder that is highly prevalent among older adults. anxiety and gad is a well-documented risk factor for the development of other severe conditions such as depression and dementia, and effective treatments are called for. however, recommended treatment for gad has consistently been found to yield blunted response rates for older adults compared to younger patients. the purpose of this study is to evaluate the effects of exercise-augmented cognitive behaviour therapy for older adults with gad. exercise augmented cbt is expected to yield better results than standard cbt in terms of greater reduction of symptoms and increased rates of remission. the investigators will also investigate the effects of treatment on biological, physiological and neuropsychological measures.


Eligibility criteria:
inclusion criteria: * primary diagnosis of gad exclusion criteria: * substance abuse * use of benzodiazepines, use of antipsychotica * lack of ability to stabilize other psychotropic medication during participating in the study * medical condition that precludes participation in physical exercise * severe major depression as determined by the mini international neuropsychiatric interview * life-time history of psychosis and/or mania * participation in other ongoing psychotherapy * organic brain disease * positive screening for dementia with mini mental state examination * currently engaged in a regular physical exercise program

Keywords: gad cbt physical exercise older adults
a study to identify barriers to cellular therapies for people with plasma cell disorders

Conditions: Multiple Myeloma

Summary: this is an observational study that will include both participants with relapsed/refractory multiple myeloma and their doctors. the purpose of this study is to gather information about the use of hematopoietic cell transplantation/hct and b-cell maturation antigen /bcms targeted chimeric antigen receptor/car autologous t-cell therapy.


Eligibility criteria:
inclusion criteria: patient * diagnosis of multiple myeloma after january 1, 2017. * karnofsky performance status \> 70% * ≥ 2 lines of prior therapy * anticipated to start new a line of therapy for rrmm within the next 12 months * age 18-80 years of age. * english or spanish speaking. * willing to provide informed consent * willing to perform study procedures. physician investigator * be a co-investigator * agree to comply with study procedures exclusion criteria: patient * active cns disease * patients who already have a definitive plan are to be excluded

Keywords: multiple myeloma bcma car t-cell therapy hct memorial sloan kettering cancer center 23-166
post market clinical follow up study for reliatack™ articulating reloadable fixation device with deep purchase tacks

Conditions: Inguinal Hernia; Ventral Hernia

Summary: a post-market clinical follow-up study for reliatack™ articulating reloadable fixation device with deep purchase tacks

a retrospective, multi-center, chart review of medical records on the use of the device for two (2) surgical procedure indications: 1. inguinal/femoral hernia 2. ventral hernia a minimum of 4 sites in the united states will perform chart review and enter 116 study records in the database for data collection. the 116 subject records will be comprised of 76 for the inguinal/femoral indication, and 40 for the ventral indication.

Eligibility criteria:
inclusion criteria: 1. subject underwent ventral or inguinal/femoral hernia repair procedure utilizing reliatack™ articulating reloadable fixation device with deep purchase tacks on or after 510(k) approval. 2. medical records are available, which document a ventral and/or inguinal/femoral hernia repair surgical procedure. exclusion criteria: 1. institutional review board (irb) consent requirement cannot be met: 1. waiver of subject informed consent requirements are not granted by irb\* and, 2. an altercation to the consent process is not granted by the irb and, 3. subject or subject's parent or legal guardian is unable or unwilling to provide signed informed consent 2. subject was participating in any investigational drug or device study at the time of surgery or within 30-day (+3 days) study window 3. subject was pregnant at the time of procedure 4. subject had a documented allergy at the time of surgery to any of the components of the device or the mesh implant 5. subject was treated with any other implantable mechanical fixation device, other than sutures * a waiver of subject informed consent procedures will be requested from all irbs of record for this study.
evaluation of the quality of self-collected blood spot specimens for laboratory hiv testing - an involvement sub study

Conditions: HIV

Summary: we will invite a convenience sample of up to 45 enrolled subjects to participate in an optional, self-administered blood specimen collection procedure to determine optimal procedures for collection.

participants will be recruited to this one-time assessment during their follow-up visits. after completing a consent procedure specific to this study component, participants will be provided with instructions on how to fully self-administer the procedure of a finger stick and also blotting to collect a blood specimen using a 1, 3 or 5 blood spot specimen collection card. these specimens will be labeled with the participant's unique identification number, and no other identifying information. the dried blood spots will be evaluated by a laboratorian to assess quality, but will not be tested for hiv. this evaluation will help determine what number of self-collected dried blood spots yields the highest usable quantity of sample for hiv testing. there will be a separate monetary incentive of $30 for this procedure.

Eligibility criteria:
inclusion criteria: * must be either currently enrolled or previously enrolled in the involvement study through emory university * over 18 years old * hiv negative exclusion criteria: * not enrolled or previously enrolled in the involvement study through emory university * under 18 years old * hiv positive
freeze-all policy in poor responders

Conditions: Infertility, Female

Summary: to compare the effects of fresh embryo transfers (et) and elective frozen-thawed embryo transfer cycles in poor ovarian responders.


Eligibility criteria:
inclusion criteria: * all patients that fulfill the bologna criteria \[at least 2 of the following 3 features must be present: (i) advanced maternal age or any other risk factor for por; (ii) a previous por; and (iii) an abnormal ovarian reserve test (ort)\] * if the progesterone serum level was ≤1.5 ng/ml on the trigger day. * body mass index 18-32 kg/m2 * both partners are able to provide written informed consent. * at least 1 good quality embryo on day 3 after egg collection on day 3 according to the istanbul consensus (7-8 cells; with symmetric blastomeres and \<10% fragmentation by volume). * endometrial thickness ≥8 mm on trigger day. * a normal uterine cavity on ultrasound. * ivf/icsi with only fresh semen exclusion criteria: * pre-implantation genetic testing is being planned. * if they had severe endometriosis, uterine pathology (myomas, adenomyosis, endocrinopathies, adhesions, acquired or congenital abnormalities), untreated tubal hydrosalpinges, ovarian tumor, recurrent spontaneous abortion, implantation failure after ≥ 2 fresh or frozen et.
release of cytokines by stimulated peripheral blood mononuclear cells (pbmc) from chronic periodontitis subjects

Conditions: Periodontitis

Summary: background and objective: it has been reported that peripheral blood mononuclear cells (pbmc) from periodontal patients have a different profile of cytokine release when compared to the ones of healthy patients. cigarette smoking is a recognized risk factor for periodontitis and is known to affect the systemic and local immune responses. thus, the aim of the present study was to obtain preliminary data about the interaction of periodontal condition and smoking in the secretion of some cytokines by pbmc. material and methods: pbmc samples were isolated from 19 donors, divided into generalized chronic periodontitis (p; n=10) and periodontal health (h; n=9) groups. in addition, the smokers and non-smokers of each group were separately evaluated: sp- smokers with severe generalized chronic periodontitis (n=5); sh- periodontally healthy smokers (n=5); nsp- non-smokers with severe generalized chronic periodontitis (n=5) and nsh- periodontally healthy non-smokers (n=4). cells were incubated for 24-48 hours in 500 µl wells containing rpmi 1640 and stimulated with 1.0 ng/ml of e. coli lps. supernatants were used to quantify the amounts of tnf-α, il-6, il-8 and il-10 released using elisa kits.


Eligibility criteria:
inclusion criteria: * periodontitis exclusion criteria: * diabetes

Keywords: periodontitis find cytokines in blood of periodontal patients
dexamphetamine sustained release pharmacokinetics and clinical validation of dried blood spots

Conditions: Cocaine Addiction

Summary: the pharmacokinetics of 10 to 12 individuals receiving 60 mg of sustained release dexamphetamine will be studied. these individuals have received this medication before in a previous trial where the pharmacodynamics were investigated. this trial will last 5 consecutive days during which blood samples will be drawn for pharmacokinetics analyses. dried blood spots will also be collected for the clinical validation of the bioanalytical method wherein these are used.


Eligibility criteria:
inclusion criteria: * have completed at least 80% of the previous study (catch) * be able and willing to participate in the study and assessments * have provided written informed consent. exclusion criteria: * any intake of dexamphetamine 7 days or less before the start of the proposed study; * contraindications for dexamphetamine * (desired) pregnancy or continued lactation * insufficient command of the dutch language * current participation in another trial